U.S. patent application number 11/743858 was filed with the patent office on 2007-11-08 for apparatus and method of inhibiting perianal tissue damage.
This patent application is currently assigned to PLEXUS BIOMEDICAL, INC.. Invention is credited to David D. Blurton, Hai Trieu.
Application Number | 20070260163 11/743858 |
Document ID | / |
Family ID | 38668555 |
Filed Date | 2007-11-08 |
United States Patent
Application |
20070260163 |
Kind Code |
A1 |
Blurton; David D. ; et
al. |
November 8, 2007 |
Apparatus and Method of Inhibiting Perianal Tissue Damage
Abstract
A perianal support device is provided that is configured to
inhibit the formation and/or progression of tissue damage in the
perianal region of the body. A method is provided to apply the
perianal support device to patients during childbirth to inhibit
the formation and/or progression of tissue damage in the perianal
region of the body.
Inventors: |
Blurton; David D.;
(Whiteville, TN) ; Trieu; Hai; (Cordova,
TN) |
Correspondence
Address: |
HAYNES AND BOONE, LLP
901 MAIN STREET, SUITE 3100
DALLAS
TX
75202
US
|
Assignee: |
PLEXUS BIOMEDICAL, INC.
Memphis
TN
|
Family ID: |
38668555 |
Appl. No.: |
11/743858 |
Filed: |
May 3, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60746283 |
May 3, 2006 |
|
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|
Current U.S.
Class: |
602/1 |
Current CPC
Class: |
Y10S 128/25 20130101;
A61B 17/42 20130101; A61F 5/0093 20130101 |
Class at
Publication: |
602/001 |
International
Class: |
A61F 5/00 20060101
A61F005/00 |
Claims
1. An apparatus, comprising: a perianal support member having a
first side and an opposite second side, the first side including a
pressure surface configured for engagement with tissue adjacent an
anal orifice; and a pair of substantially rigid sidewalls extending
from said second side, the sidewalls each having exterior surfaces
and interior surfaces, the interior surfaces defining an access
passage to the second side.
2. The apparatus of claim 1, wherein the exterior surfaces of the
side walls define an external angle therebetween, said external
angle less than 120 degrees.
3. The apparatus of claim 2, wherein said external angle is less
than 90 degrees.
4. The apparatus of claim 3, wherein said external angle is between
90 and 60 degrees.
5. The apparatus of claim 4, wherein said external angle is between
80 and 60 degrees.
6. The apparatus of claim 1, wherein said internal walls define an
internal angle therebetween, said internal angle less than 120
degrees.
7. The apparatus of claim 6, wherein said internal angle is less
than 90 degrees.
8. The apparatus of claim 7, wherein said internal angle is between
90 and 60 degrees.
9. The apparatus of claim 8, wherein said external angle is between
80 and 60 degrees.
10. The apparatus of claim 1, wherein said external side walls are
generally parallel to the respective internal side walls.
11. The apparatus of claim 1, wherein said external side walls and
said internal walls define a substantially V-shaped perianal
support device.
12. The apparatus of claim 1, wherein said second surface is within
2 cm of said pressure surface.
13. The apparatus of claim 1, further including a flexible anchor
member joined to at least one of said side walls.
14. A perianal support device, comprising: a compression body
having compression surface configured for engagement with at least
a portion of the perianal tissue of a patient, said compression
surface oriented in a first direction; and a compression member
having a proximal portion and a distal portion, said compression
member operatively joined to said compression body adjacent said
distal portion and extending therefrom in a second direction to
said proximal portion, said second direction generally transverse
to said first direction, said compression member configured to
transmit compressive force applied adjacent said proximal portion
to said compression surface.
15. The device of claim 14, further including at least a second
compression member joined to said compression body.
16. The device of claim 15, wherein said second compression member
extends in a third direction substantially transverse to said first
direction and at an angle with respect to said second
direction.
17. The device of claim 16, wherein said angle is between 130 and
30 degrees.
18. The device of claim 17, wherein said angle is between 100 and
70 degrees.
19. The device of claim 14, wherein said compression member
includes an engagement surface for joining to an anchoring
member.
20. A method, comprising: providing a support member having a
pressure surface configured for engaging the perianal area of a
patient and an elongated compression member; positioning the
pressure surface proximate the perianal area of a patient and the
compression member extending outwardly beyond the crown of the
buttocks; and applying pressure to the compression member to direct
pressure through the pressure surface against the perianal area of
the patient.
21. The method of claim 20, further including securing at least the
compression member against movement.
22. The method of claim 21, wherein the securing includes adhering
a portion of an elongated member to the patient.
23. The method of claim 21, wherein the securing includes affixing
an anchor to the patient and joining a portion of an elongated
member to the anchor.
24. The method of claim 20, further including providing an
elongated fixation member joined to the compression member and said
applying pressure includes tensioning the elongated fixation
member.
25. The method of claim 24, further including securing the
elongated fixation member to the patient after said tensioning.
26. The method of claim 25, wherein said securing includes moving
the elongated fixation member laterally away from the anal orifice
and fixing to a lateral flank of the patient.
27. A method of inhibiting perianal tissue damage during
childbirth, comprising: positioning a perianal support device in
contact with at least a portion of the perianal tissue of the
patient prior to delivery of a child; positioning a compression
member associated with the support device to extend outwardly in
the saggital plane beyond a gluteal cleft; securing the position of
the compression member relative to the perianal tissue, to thereby
maintain the position of the perianal support device.
28. The method of claim 27, wherein said positioning of the
perianal support device in contact with at least a portion of the
perianal tissue is performed concurrently with said positioning a
compression member.
29. The method of claim 27, wherein said securing includes moving
an elongated fixation member connected to the compression member to
a securing position.
30. The method of claim 29, wherein moving said elongated fixation
member includes extending the elongated fixation member generally
laterally away from the perianal tissue.
31. The method of claim 30, further comprising securing the
elongated fixation member to a lateral flank of the patient.
32. The method of claim 31, wherein said securing includes adhering
at least a portion of the elongate fixation member to the patient's
skin.
33. The method of claim 31, wherein said securing includes engaging
the elongate fixation member with an anchor.
34. The method of claim 33, further including securing an anchor to
the patient prior to said engaging.
35. A system for perianal tissue support, comprising: a support
body having a perianal tissue pressure member extending along a
midline axis; and a lateral anchoring assembly joined to said body
and extending away from said body in a direction substantially
transverse to the midline axis.
36. The system of claim 35, wherein said body includes a least one
lateral side wall spaced from the midline axis, said lateral side
wall configured for engagement with tissue disposed laterally
adjacent the perianal region.
37. The system of claim 35, wherein said pressure member includes
first length extending along the midline axis and said body further
includes a compression member having a second length extending
along a second axis, said second length greater than said first
length.
38. The system of claim 35, wherein said second axis is disposed
substantially transverse to said midline axis.
39. An apparatus to support perianal tissue of a patient,
comprising: a perianal support device configured to be received
within a portion of a gluteal cleft extending generally from a
vagina to the coccyx, the gluteal cleft extending generally in a
sagittal plane, the support device adapted to engage at least a
portion of the perianal tissue of the patient; and a means for
securing the perianal support device in a support position on the
patient, said means for securing configured to extend substantially
perpendicular to the sagittal plane.
40. The apparatus of claim 39, wherein said means for securing
includes a flexible member for releasably joining to the
patient.
41. The apparatus of claim 39, wherein said perianal support device
includes an elongated body portion extending for a length in the
saggital plane, the gluteal cleft having a depth, said length
greater than said depth.
42. The apparatus of claim 39, wherein said perianal support device
is wedge shaped.
43. The apparatus of claim 42, wherein said perianal support device
defines an internal access cavity.
44. The apparatus of claim 43, wherein said perianal support device
is V-shaped.
45. The apparatus of claim 39, wherein the means for securing
includes a first portion attached to the perianal support device
and an anchor spaced from the perianal support device, the first
portion engagable with the anchor.
46. A support device for use on a patient, comprising: a body
configured for at least partial placement in the cleft of the
buttocks, the cleft having a depth measured in the sagittal plane
of the patient, the body having a contact surface configured to
support a perianal region and a compression member extending from
said body, said compression member extending a distance measured in
the saggital plane, said distance greater than said depth.
47. The device of claim 46, wherein said compression member extends
substantially along the sagittal plane of the patient.
48. The device of claim 46, wherein said compression member extends
at a first angle with respect to said sagittal plane of the
patient.
49. The device of claim 48, further including a second compression
member extending from said body, said second compression member
extending at a second angle with respect to the sagittal plane
complimentary to the first angle.
50. The device of claim 46, wherein said compression member is
integral with said body.
51. The device of claim 49, wherein said body, compression member
and second compression member form a V-shape.
52. The device of claim 51, wherein the V-shape has an apex and a
pair of legs extending from the apex, said contact surface is
positioned adjacent the apex of the V-shape and the pair of legs
extending from the apex are the compression members.
53. The device of claim 46, further including an anchor system for
maintaining the position of the contact surface in the perianal
region, said anchor system operatively engaged with said
compression member.
54. The device of claim 53, wherein said anchor system includes a
flexible member.
55. The device of claim 54, wherein said anchor system includes a
patient fixation component configured for attachment to the
patient.
56. The device of claim 55, wherein said patient fixation component
includes an adhesive segment to adhere at least a portion of the
anchor member to the patient's skin.
57. The device of claim 55, wherein a first component of the
patient fixation component is an adhesive pad adapted to adhere to
the patient and a second component is joined to said compression
member and removably attachable to said first component.
58. The device of claim 57, wherein said first component includes a
first half of a hook and loop fastening system and said second
component includes an opposing half of the hook and loop fastening
system such that the first component may be removably connected to
the second component.
59. A perianal support device, comprising: a perianal support body
having a pressure surface configured to engage perianal tissue; and
a means for applying pressure, said means for applying pressure
having a first portion engaged to the support body and a second
portion extending away from the support body, said means for
applying pressure configured to force the pressure surface to press
against the perianal tissue.
60. The device of claim 59, wherein said means includes a
substantially rigid compression member extending outwardly from the
support body.
61. The device of claim 60, further including a tension member
joined to the compression member.
62. The device of claim 61, wherein the tension member includes a
securing mechanism for anchoring the tension member.
63. The device of claim 62, wherein the securing mechanism includes
an adhesive.
64. The device of claim 62, wherein the securing mechanism includes
at least one portion of a hook and loop fastening system.
65. A kit for providing perianal support, the kit comprising: a
perianal support body having a pressure surface configured to
engage perianal tissue, the pressure surface having a length; and a
compression system having a first portion configured for engagement
with the support body and a second portion spaced from the support
body greater than said length, said compression system configured
to load the pressure surface into compressive contact with the
perianal tissue.
66. The kit of claim 65, wherein the compression system includes at
least one strap pre-assembled with the support body.
67. The kit of claim 65, wherein the compression system is provided
in the kit separate from the support body.
68. The kit of claim 65, further including a treating compound.
69. The kit of claim 68, wherein the treating compound is provided
in a separate package within the kit.
70. The kit of claim 68, wherein the treating compound is provided
on the support body within the kit.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application claims the priority of U.S.
Provisional Patent Application Ser. No. 60/746,283 filed May 3,
2006, the contents of which are hereby incorporated by reference in
its entirety. U.S. patent application Ser. No. 11/197,627 filed
Aug. 5, 2005 entitled Method, Apparatus and System for Preventing
or Reducing the Severity of Hemorrhoids commonly assigned to the
present applicant is hereby incorporated by reference in its
entirety.
BACKGROUND
[0002] The disclosed embodiments relate to a method and apparatus
for inhibiting perianal tissue damage. The child birthing process
is a traumatic event for a women's body and can result in tissue
damage; such as fissures, tears and bulging, in and around the anus
as a result of pushing the baby into and/or through the birthing
canal. Even when labor does not result in a vaginal delivery, the
process of pushing during labor may also result in the development
of or increase in severity of hemorrhoids. Current birthing
techniques do not provide an apparatus or method for supporting the
soft perianal tissues near the anal orifice.
[0003] Thus, there is a need for devices and methods that provide
support to the perianal tissues. In some aspects, these devices and
methods may be useful in preventing or reducing the severity of
hemorrhoids and other tissue damage, during the child birthing
process.
SUMMARY
[0004] In one embodiment, a system for perianal tissue support is
provided. The support includes a support body having a midline
perianal tissue pressure member with a lateral anchoring assembly
joined to the support body and extending away from the support body
in a direction substantially transverse to the midline of the
pressure member. In a further aspect, the anchoring assembly
includes a mechanism for applying force to the support body to
compressively load the pressure member against the perianal tissue
of the patient.
[0005] In another embodiment, a support device for use on a patient
is provided. The support device comprises a body configured for at
least partial placement in the cleft of the buttocks, the cleft
having a depth measured in the sagittal plane of the patient. The
body includes a contact surface configured to support a perianal
region and a compression member extending from the body. The
compression member has a length in the saggital plane that is
greater than the depth of the gluteal cleft.
[0006] In still a further embodiment, a method is provided. The
method includes providing a support member having a pressure
surface configured for engaging the perianal area of a patient and
an elongated compression member. The method includes positioning
the pressure surface proximate the perianal area of a patient with
the compression member extending outwardly beyond the crown of the
buttocks, and applying pressure to the compression member to direct
pressure through the pressure surface against the perianal area of
the patient. In one aspect, the method includes securing at least
the compression member to inhibit movement. In still a further
aspect, the securing includes adhering a portion of an elongated
member to the patient.
[0007] In yet another embodiment, there is provided a kit for
applying to the perianal region of a patient. In one aspect, the
kit includes a perianal support member and an anchoring system. In
a further aspect, the anchoring system includes a mechanism for
applying force to the perianal support member to compressively load
the perianal tissue of the patient. In a further aspect, the kit
includes a treating compound.
[0008] In one embodiment, a perianal support device for a patient
is provided. The device comprises a perianal support body having a
pressure surface configured to engage perianal tissue and a system
for applying pressure. The pressure applying system has a first
portion engagable to the support body and a second portion
extending away from the support body. The pressure applying system
is configured to force the pressure surface to press against the
perianal tissue.
[0009] In a further embodiment, a method is provided for fixing a
perianal support device to a patient to compressively load the
perianal tissue.
[0010] Further aspects, forms, embodiments, objects, features,
benefits, and advantages of the present disclosure shall become
apparent from the detailed drawings and descriptions provided
herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective view of one aspect of an apparatus
according to a first embodiment;
[0012] FIG. 2 is a perspective view, opposite to the view of FIG.
1, of the apparatus of FIG. 1;
[0013] FIG. 3 is a partial perspective bottom view of the apparatus
of FIG. 1 affixed to a patient during child delivery;
[0014] FIG. 4 is a partial cross sectional top view of FIG. 3,
showing stylized patient anatomy and the applied apparatus;
[0015] FIG. 5 is a perspective view of another embodiment of the
present invention;
[0016] FIG. 6 is an end view of the apparatus of FIG. 5;
[0017] FIG. 7 is a side view of the apparatus of FIG. 5;
[0018] FIG. 8 is a perspective view of one aspect of the base of
the apparatus of FIG. 5;
[0019] FIG. 9 is a perspective view of a further embodiment of the
present invention;
[0020] FIG. 10 is an end view of the apparatus of FIG. 9;
[0021] FIG. 11 is a side view of the apparatus of FIG. 9;
[0022] FIG. 12 is a first perspective view of a still a further
embodiment according to another aspect of the present
invention;
[0023] FIG. 13 is a second perspective view, of the embodiment of
FIG. 12;
[0024] FIG. 14 is a perspective view of another embodiment
according to a further aspect of the present invention;
[0025] FIG. 15 is a top view of the embodiment of FIG. 14;
[0026] FIG. 16 is an end view of the embodiment of FIG. 14;
[0027] FIG. 17 is a perspective view of a system according to one
aspect of the present invention;
[0028] FIG. 18 is a perspective view of a further embodiment
according to another aspect of the present invention;
[0029] FIG. 19 is a partial cross sectional top view of the
embodiment of FIG. 18 applied to a patient with stylized depiction
of the patient anatomy; and
[0030] FIG. 20 is a partial perspective view of a device according
to the present invention applied to a patient during child
delivery.
DETAILED DESCRIPTION
[0031] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It will nevertheless be
understood that no limitation of the scope of the disclosure is
intended. Any alterations and further modifications in the
described devices, instruments, methods, and any further
application of the principles of the disclosure as described herein
are contemplated as would normally occur to one skilled in the art
to which the disclosure relates. In particular, it is fully
contemplated that the features, components, and/or steps described
with respect to one embodiment may be combined with the features,
components, and/or steps described with respect to other
embodiments of the present disclosure.
[0032] Referring now to FIGS. 1-4, a support system according to
one embodiment of the present invention is illustrated in
association with the perianal tissue of a patient 10. In FIG. 4,
the patient 10 is shown in partial cross section to illustrate a
portion of the rectum 54, anal canal 36, anal orifice 38, internal
venous plexus 29, pectinate line 37 (also known as the dentate
line), and external venous plexus 28. The patient's buttocks 14 and
15 are shown with the crown of the buttocks 16 and 17,
respectively, laterally adjacent the perianal region 26. The
gluteal cleft 13 (FIG. 3) is between buttocks 14 and 15. The
buttocks 14 and 15 extend laterally beyond crowns 16 and 17 toward
lateral flanks 18 and 19, respectively. The crowns 16 and 17 of
each buttocks 14 and 15 in essence define the midline of each leg
and the lateral flanks 18 and 19 are the area lateral of the
leg/buttocks midline. The lateral flanks 18 and 19 may include, for
example but without limitation, all or a portion of the lateral
buttocks, hips, or upper thigh of the patient.
[0033] During the child birthing process, contractions during labor
move a child 12 into the birth canal and ultimately, for a vaginal
delivery, through the vaginal opening 11, as shown in FIG. 3. In an
alternative birthing process, labor is commenced to move the child
12, but for a variety of reasons, the delivery does not occur
vaginally but instead caesarian delivery is performed through a
surgical opening in the mother's abdomen. During the birthing
process, tremendous pressure is exerted in an effort to move the
child toward delivery. At least some of this pressure is exerted
against the tissues adjacent the anal orifice 38 in the perianal
region 26. The result of these forces is that blood vessels near
the anus, such as those in the external venous plexus 28, may bulge
or rupture causing hemorrhoids or increasing their severity. Still
further, other tissues in the perianal region 26 adjacent the anus
may distend outwardly opposite arrow A1 in FIG. 4 causing
lacerations such as tearing around the vaginal opening or fissures
from the anus. In addition to the blood loss, pain, and discomfort,
these lacerations can be a location for infections in the mother.
The present invention provides devices to support the perianal
tissues during the birthing process without interfering with the
birthing canal or vaginal opening 11 and/or allowing easy removal
to access the perianal region 26. Still further, methods are
provided to support the perianal tissue to inhibit damage to the
tissue near the anal orifice 38, both internally and externally, to
inhibit, for example but without limitation to other actions, the
formation or advancement of external hemorrhoids and/or to inhibit
the formation or advancement of lacerations of the perianal
tissues.
[0034] Referring to FIGS. 1 and 2, there is shown an embodiment of
one aspect of a tissue support device 20 according to the present
invention. Support device 20 includes a base 22 having a raised
portion 24 extending generally along contact axis 48. In the
illustrated embodiment, the raised portion 24 defines a partial
cylinder having a curved pressure surface 30 oriented to extend
along contact axis 48 between the posterior end 31 and the anterior
end 32. A first flange 60 has a first end portion 62 joined to the
raised portion 24 and an opposing second end portion 64. An
opposing second flange 66 has a first end portion 68 joined to the
raised portion 24 and an opposing second end portion 70. The device
20 includes an outer surface 33 and an opposing inner surface 34
defining an access cavity 65. As shown in FIGS. 3 and 4, a securing
member 80 is attached to first flange 60 adjacent end portion 64.
In a similar manner, a second securing member 81 is attached to
second flange 66 adjacent end portion 70. In the illustrated
embodiment, securing members 80 and 81 are elongated, flexible
strips of adhesive tape. Midline end portions 82 and 83 of the
securing members 80 and 81 are adhered to the inner surface 34 of
the support device 20 while the opposing lateral ends 84 and 85
extend outwardly laterally from the midline or contact axis 48 of
the device.
[0035] Referring to FIG. 4, in use, a health care provider
positions the patient 10 to expose the perianal region 26. In the
child birthing process, the patient 10 may be positioned in
stirrups attached to a delivery table (not shown). The perianal
support device 20 is then moved adjacent the gluteal cleft 13
between buttocks 14 and 15. The support device 20, is positioned
such that the midline 48 of the support device is substantially
aligned with the patient's midline within the sagittal plane.
Referring to FIG. 4, the support device 30 is advanced in the
direction of arrow A1 toward the anal orifice 38 (generally within
the sagittal plane toward the head of the patient) to bring
pressure surface 30 into contact with the perianal tissues.
Continued advancement of the support device 20 toward the anal
orifice 38 applies pressure through the pressure surface 30 to the
perianal tissues. In one aspect, the healthcare provider places at
least one finger within the access cavity 65 and preferably against
internal contact surface 35 to advance the device against the anal
orifice 38. With continued pressure applied by the healthcare
provider to the access cavity 65, and/or internal contact surface
35, fixation member 80 is extended laterally of the anal orifice 38
out of the gluteal cleft 13 and releasably attached to the patient
10 to at least the lateral flank 18. In a similar manner, with
compressive force applied by the healthcare provider to support
device 20, elongate fixation member 81 is extended laterally of the
anal orifice 38 out of the gluteal cleft 13 and is secured to the
patient adjacent lateral flank 19. Thus, the fixation members 80
and 81 of the system do not extend along the patient midline in the
gluteal cleft 13 with the potential for interference with the
birthing process, but instead extend substantially laterally from
the patient's midline out of the gluteal cleft 13 and are attached
at the patient's lateral flanks 18 and 19.
[0036] The extent of tissue deformation surrounding the anal
orifice 38 when device 20 is applied is a function of the patient
anatomy and of the amount of compressive force applied during
application of the support device 20. As shown in FIG. 4, the
maximum extent of perianal tissue engagement inwardly on the
patient in the saggital plane is shown by line 50. In one aspect,
it is contemplated that pressure applied in the direction of arrow
A1 moves the anal orifice inwardly 1 cm to 3 cm. In one embodiment,
the lateral ends 84 and 85 of the fixation members 80 and 81 extend
beyond line 50 generally in the patient's saggital plane. The
fixation members 80 and 81 exert tension forces generally in the
direction of arrows A2 and A3, respectively. This tension force is
applied to flanges 60 and 66, which are substantially rigid members
capable of transmitting compressive forces to the raised body 24.
The tension force applied on the lateral flanks 18 and 19 of the
patient 10 in the direction of arrows A2 and A3 is converted to
compressive forces in the direction of arrows A4 and A5,
respectively. The compressive forces A4 and A5 are transmitted by
substantially rigid flanges 60 and 66 to raised body 24 and
ultimately to compression surface 30 to apply support and/or
pressure to the perianal tissues in the direction of arrow A1. It
will be appreciated that the lateral components of compressive
forces applied in A4 and A5 helps to maintain the position of
device 20 as well as tending to maintain access cavity 65 in an
open position.
[0037] As shown in FIG. 4, flanges 60 and 66 each extend for a
length 76 from the internal contact surface 35 to their proximal
ends 64 and 70, respectively. In one aspect, length 76 is greater
than 5 cm but less than 20 cm. In the illustrated embodiment,
length 76 is approximately 8 cm. The flanges 60 and 66 extend away
from each other to define access cavity 65 by an internal angle 75.
In one aspect, the angle 75 is between 30 and 140 degrees. In the
illustrated embodiment, angle 75 is approximately 90 degrees. The
distance 77 between the anal orifice and the buttocks crown 16 is
less than the distance 79 between the distal end 64 of the flange
60 and the anal orifice. Thus, tension applied to fixation members
80 and 81 is transferred through substantially rigid flange 60 to
exert a compressive force on pressure surface 30 in the direction
of arrow A1. Whereas, if distance 77 is greater than distance 79
tension applied to fixation members 80 and 81 may pull the device
20 in a direction opposite arrow A1.
[0038] It will be appreciated that with the illustrated embodiment,
the healthcare provider may reposition the device 20 and adjust the
compressive force applied through the fixation members 80 and 81 to
the pressure surface 30 by releasing or adjusting the attachment
between the fixation members 80 and 81 and the patient 10.
[0039] Referring now to FIGS. 5-8, there is shown a further
embodiment of a tissue supporting apparatus according to the
present invention. Similar references numerals will be used to
refer to components similar to the previously described embodiment.
Device 40 comprises a base 22 having an extending raised portion 44
that, when positioned against a patient 10 (see FIGS. 3 and 4),
applies pressure to a perianal region 26 adjacent to an external
rectal venous plexus 28 to support the perianal tissue to prevent
and/or reduce the severity of hemorrhoids and other tissue damage.
The device may be secured to the patient as described above. Base
22 may be integrally formed with the raised portion, such as raised
portion 24 shown in FIG. 1, or alternatively base 22 and the raised
portion 44 may be removably connected, such as shown in FIGS. 5-8.
For example, device 40 further includes a securing mechanism 42
operable to fix base 22 to the raised portion 44. For example,
securing mechanism 42 may include, but is not limited to, one or
any combination of an interlocking mechanical interface, such as a
dovetail, a separate mechanical connector, or a chemically-based
fixator, such as a glue.
[0040] In still a further embodiment illustrated in FIGS. 9-11, the
device 90 includes a raised portion 94 attached to base 22 having
outwardly extending legs 60 and 66 defining a V-shaped body.
Extending from the pressure surface 30 is a plug portion 96 may be
shaped and sized for insertion within anal canal 36 of patient 25.
All or a portion of plug 96 may provide pressure to oppose the
distension of vascular tissue, such as internal rectal venous
plexus 29 and external rectal venous plexus 28, shown in FIG. 4, by
placement within anal canal 36 and/or adjacent rectum 54. As such,
plug portion 96 may apply pressure to prevent or reduce the
severity of thrombosed internal hemorrhoids. Plug portion 96 has an
enlarged distal end to resist expulsion from anal canal 36. It will
be appreciated that pressure surface 30 may be substantially rigid
in comparison to the adjacent soft tissue while plug portion 96 may
be formed a significantly more pliable material that is deformable
as the child 12 passes through the birth canal and out of the
vaginal opening 11. The flanges 60 and 66 are configured to engage
the skin of the patient laterally adjacent the anal orifice and
assist in maintaining the position thereof. It will be appreciated
that in addition to the enlarged plug 96 and flanges 60 and 66,
fixation members 80 and 81 may also be used to maintain the
position of the device on the patient and supply compressive force
to compression surface 30.
[0041] Referring now to FIGS. 12 and 13, support device 100 is
shown as a further embodiment of the present invention. Support
device 100 includes a base member 101 with a raised compression
surface 130 configured for engagement with the anal orifice 38 and
surrounding tissue. The substantially solid base 101 has a first
lateral side wall 103 and an opposing lateral side wall extending
substantially parallel to each other and parallel to the midline of
the compression surface 130. The base has a base extension 102 that
extends from the compression surface 130 to the proximal end 110 a
distance 104. In a preferred aspect, the distance 104 is greater
than the depth of the patient's gluteal cleft 13 such that it
extends outward beyond the perimeter of the patient. The proximal
end 110 includes a channel 142. A strap or other fixation member
(not shown), such as members 80 and 81, is passed through channel
142. The fixation member is then secured to the patient 10 or to a
stationary object to secure the device 100 in position and allow
the base extension 102 to be utilized to aid in transferring force
from base 101 to compression surface 130. In one aspect, the base
101 is a substantially solid, rigid member formed from a unitary
material. In another aspect, the compression surface 130 is formed
of a more compliant material than the material forming base
101.
[0042] Additionally, flanges 60 and 66 may be positioned so as to
extend away from base portion 72 and/or a respective raised
portions 24, 44 and 94. Further, flanges 60 and 66 may be
respectively positioned at a predetermined angle 75 such that
flanges 60 and 66 diverge as they extend away from respective
raised portion 24, 44 and 94. For example, in some aspects,
predetermined angle 75 may be in the range of about 50 degrees to
about 120 degrees, while in other aspects predetermined angle 75
may be in the range of about 70 degrees to about 90 degrees, while
in other aspects predetermined angle 75 may comprise any angle
operable to position flanges 60 and 66 against the local anatomy of
patient 10 while positioning the respective raised portion 24, 44
and 94 in perianal region 26 to apply pressure to prevent or reduce
the severity of hemorrhoids.
[0043] Additionally, in the illustrated embodiments, each device
20, 40, 90, and 100 are sized and positioned with respect to
patient 10 to allow for the passage of a child through the birthing
canal during childbirth. It is contemplated that the devices may be
placed to support more or less of the perineum between the anus and
vaginal opening depending on the health care provider's judgment
and the progress of the child birthing process. Still further, it
is contemplated that an elongated anterior to posterior device may
be positioned to support at least a portion of the perianal tissue
and the vaginal tissue during the labor process. It is anticipated
that the supporting device will be repositioned posteriorly away
from the vaginal opening prior to delivery of the child through the
vaginal opening.
[0044] Devices 20, 40, 90, and 100 may be formed of a raised
portion that generally conforms to the patient's anatomy, while the
base is substantially rigid so as to resist deformation and
transfer compressive force from fixation mechanism to raised
portion. For example, the raised portion may be formed from one or
any combination of silicone or any type of elastomeric material,
while base may be formed from a plastic, vinyl, polyvinylchororide,
acrylic, and/or polycarbonate material. In other aspects, the
entire device 20, 40, 90, and 100 may be substantially rigid.
[0045] Referring now to FIGS. 14-16, there is shown another
embodiment of a perianal support device 300 according to the
present invention. Support device 300 includes a base 310 having an
external pressure surface 312. The external pressure surface 312
extends along midline axis 320 between first end 314 and opposing
second end 316. A pair of opposing compression members 330 and 340
is joined to base 310. In the illustrated embodiment, compression
members 330 and 340 are integral with and define a portion of base
310. The compression member 330 includes a distal end 332
transitioning into pressure surface 312, an elongated, planar
exterior side wall 334 extending from distal end 332 to proximal
end 336. The compression member 330 extends generally along axis
322 which is substantially transverse to midline axis 320 as shown
in the top view of FIG. 15. In the end view of FIG. 16, it is shown
that compression member 330 extends at an oblique angle with
respect to axis 326. It will be understood that axis 326 is also
representative of the sagital plane of the body and midline axis
320 extends generally within the sagittal plane. In a similar
manner, the compression member 340 includes a distal end 342
transitioning into pressure surface 312, an elongated, planar
exterior side wall 344 extending from distal end 342 to proximal
end 346. The compression member 340 extends generally along axis
324 which is substantially transverse to midline axis 320 as shown
in the top view of FIG. 15. In the end view of FIG. 16, it is shown
that compression member 340 extends at an oblique angle with
respect to axis 326. It will be appreciated that in the illustrated
embodiment, compression member 330 extends at an oblique angle
substantially equal to the oblique angle at which compression
member 340 extends with respect to axis 326.
[0046] The perianal support device 300 has an internal contact
surface 313 defined along the midline 320 opposing the exterior
pressure surface 312. It will be understood that a health care
provider may apply pressure to the contact surface 313 to move the
support device 300 into the operative position and/or apply
additional pressure to compress at least some perianal tissues. The
compression member 330 includes an interior wall 338 while
compression member has an opposing interior wall 348 generally
facing interior wall 338. The interior walls 338 and 348 along with
internal contact surface 313 define an access cavity 350 within the
perianal support device. As shown in FIG. 16, the configuration of
the base 310 as described above results in a generally wedge shaped
device. Still further, with the inclusion of the access cavity 350,
the base 310 has a substantially V-shaped configuration with the
pressure surface 312 defined at the apex of the V and the
compression members 330 and 340 forming the legs of the V.
[0047] Referring now to FIG. 17, there is shown an embodiment of a
support system 400 according to another aspect of the present
invention. Support system 400 includes perianal support device 300
as previously described with respect to FIGS. 14-16. A compliant
pad 410 is adhered to the support device 300 across the majority of
the pressure surface 312. As illustrated, a first portion 414 of
the complaint pad 410 extends along and is adhered to distal
portion 332 of compression member 330. In a similar manner, second
portion 416 extends along and is adhered to distal portion 342 of
compression member 340. In one embodiment, the compliant pad 410 is
a sterile gauze pad. In another embodiment, the compliant pad 410
includes an internal cushioning structure, such as polyurethane,
silicon, rubber, foam, cotton, etc, with a non-abrasive skin
contact surface. In one embodiment, the compliant pad is die cut
from 1776 and 1772 stock materials from 3M. Then bonding the
resulting laminate on to the compression surface as the 1772
material has an adhesive back. In another embodiment, compliant pad
410 is an absorbent material adapted to absorb bodily fluids. It
will be appreciated that the compliant pad 410 may make placement
and maintenance of the support device 300 more comfortable for the
patient. In addition, the surface of the pad 410 is configured to
frictionally engage the patient's perianal tissue to inhibit
movement between the support device 300, particularly the pressure
surface 312 and the patient. In still a further aspect, compliant
pad 410 includes a treating compound. The treating compound is
disposed within the pad, applied on the surface, or a combination
of both. Treating compounds useful for combination with pad 410
include, but without limitation to other compounds, antibacterial
compounds, antibiotic compounds, sclerants, antimicrobial
compounds, anti-inflammatory compounds, anti-fungal agents,
anti-itching agents, humicants, moisture absorbing agents, gas
absorbing agents, buffering agents for pH control, drying agents
and the like and coagulants. In yet a further embodiment, pad 410
is not fixed to device 300 but is instead positioned on the patient
in advance of positioning device 300 or is loosely held to device
300 has it is applied to the body. In this embodiment, device 300
maintains the position of the pad 410 relative to the patient's
body and in particular the anal orifice.
[0048] The support system 400 also includes a mechanism for
securing the position of the perianal support device 300. An
elongated fixation member 420 is joined to internal surface 338 of
compression member 330. At least a portion of surface 422 of
fixation member 420 has an adhesive coating adapted for joining to
a fixed object. In a similar manner, elongated fixation member 430
is fixed to the internal surface 348 of compression member 340.
Likewise, surface 433 includes an adhesive coating that can fix the
elongated member to another object. In one embodiment, the adhesive
coating is adapted for releasably adhering to a patient's skin. In
another embodiment, the adhesive is adapted for joining to an
inanimate object or to itself. In this manner, the fixation members
420 and 430 can fix the position of the support device 300 relative
to the operating table or other fixture near the patient. In the
illustrated embodiment, the elongated fixation members 420 and 430
are formed of flexible tape. Further, while they have been
described separately, in one embodiment, the elongated fixation
members are formed by a continuous piece of material joined in the
middle to the perianal support device 300.
[0049] Referring now to FIGS. 18 and 19, there is shown a support
system 500 adapted to provide perianal support to a human patient.
Support system 500 includes the perianal support member 300 and
compliant pad 400 as discussed above. Complaint pad 410 is oriented
to extend along the midline axis 320 to thereby form a contact
surface oriented along the midline axis. In the illustrated
embodiment, the midline axis also corresponds to the apex of the
V-shaped support member. As an alternative to the embodiment
illustrated in FIG. 17, the support system of FIG. 18 includes a
pair of two part securing mechanisms. The first securing mechanism
510 includes an elongated fixation member 520 joined to the support
device 300 at medial end 521 and extending generally laterally away
from midline axis 320 in the direction of axis 322 toward lateral
end 529. The fixation member includes a first half of a releasable
fastening system on surface 522, such as a hook and loop system or
a releasable adhesive system. The second component of the securing
mechanism 510 includes an anchor pad 524. In the illustrated
embodiment, anchor pad 524 has a generally square shape that is
shorter in length and wider than elongated fixation member 520. The
shape of the anchor pad is shown for illustration purposes and may
take any form that is suitable for fixing to a patient or inanimate
object, as well as joining to the elongated fixation member. Anchor
pad 524 includes a first surface 528 having an adhesive surface
adapted for joining to the patient's skin or some inanimate object.
The opposing surface 526 includes the second half of the releasable
fastening system. In a similar manner, the second securing
mechanism 512 includes an elongated fixation member 530 joined to
the support device 300 at medial end 531 and extending generally
laterally away from midline axis 320 in the direction of axis 324
toward lateral end 539. The fixation member includes a first half
of a releasable fastening system on surface 532, such as a hook and
loop system or a releasable adhesive system. The second component
of the securing mechanism 512 includes an anchor pad 534. In the
illustrated embodiment, anchor pad 534 has a generally rectangular
shape that is shorter in length and wider than elongated fixation
member 530. Anchor pad 534 includes a first surface 538 having an
adhesive surface adapted for joining to the patient's skin or some
inanimate object. The opposing surface 536 includes the second half
of the releasable fastening system.
[0050] As shown more clearly in FIG. 19, each compression member
330/340 has a length L1 and extends away from each other by an
angle A1. The maximum lateral distance of the access cavity is
defined by the distance D1 extending between distal ends 536 and
546. In one embodiment, L1 is greater than 4 cm in length. In a
preferred aspect, L1 is approximately 8 cm. In one embodiment angle
A1, is between 140 degrees and 30 degrees. In the illustrated
embodiment, angle A1 is approximately 80 degrees. In one
embodiment, the maximum lateral distance D1 of the access cavity is
greater than 4 cm. In the illustrated embodiment of FIG. 19, the
maximum lateral distance is approximately 10 cm. It will be
understood that while compressive members 330/340 are sufficiently
rigid to transmit compressive force toward the pressure surface, in
one embodiment they are flexible, at least laterally, to bow or
bend in response to force applied to the fixation members 520/530.
In contrast, the anterior to posterior distance of the pressure
surface 312 between first end 314 and second end 316 is
approximately 5 cm in the illustrated embodiment (FIG. 14). This
midline length between the first end 314 and the second end 316 of
the device 300 can be adjusted in some embodiments depending on the
amount and extent of perianal tissue that needs to be
supported.
[0051] Referring now to FIGS. 19 and 20, the support system 500 is
illustrated in association with the perianal tissue of a patient
10. The patient 10 is shown in partial cross section to illustrate
a portion of the rectum 54, anal canal 36, anal orifice 38,
internal venous plexus 29, pectinate line 37 (also known as the
dentate line), and external venous plexus 28. The patient's
buttocks 14 and 15 are shown with the crown of the buttocks 16 and
17, respectively, laterally adjacent the perianal region. The
buttocks 14 and 15 extend laterally beyond crowns 16 and 17 toward
lateral flanks 18 and 19, respectively. The depth in the saggital
plane of the gluteal cleft 13 from the anal orifice 38 to the
buttocks crown 16 is shown by distance D2. The lateral flanks 18
and 19 may include, for example but without limitation, all or a
portion of the buttocks, hips, or upper thigh of the patient.
[0052] In use, a health care provider positions the patient to
expose the perianal region. In the child birthing process, the
patient may be positioned in stirrups attached to a delivery table.
Anchor pads 534 and 524 are adhered to the patient's skin on the
lateral flanks 18 and 19, respectively. As best seen in FIG. 20,
the anchor pads 524 and 534 are positioned on the lateral flanks 18
and 19 laterally adjacent the junction of the femur with the
pelvis. The perianal support device 300 is then moved adjacent the
gluteal cleft 13 between buttocks 14 and 15. The midline 320 of the
support device is generally aligned with the patient midline within
the sagittal plane. The support device is advanced in the direction
of arrow A1 toward the anal orifice 38 (generally within the
sagittal plane) to bring pad 410 into contact with the perianal
tissues. Continued advancement of the support device toward the
anal canal applies pressure through the pressure surface 312 and
pad 410 to the perianal tissues. In one aspect, the healthcare
provider places at least one finger within the access cavity 350
and preferably against internal contact surface 313 to advance the
device against the anal orifice. In another aspect, an instrument
having complimentary engagement surface to at least a portion of
the access cavity 350 is used to apply pressure to the device 300.
With continued pressure applied by the healthcare provider to the
access cavity 350, and/or internal contact surface 313, elongated
fixation member 520 is extended laterally of the anal orifice 38
out of the gluteal cleft 13 and releasably attached to anchor pad
524 with at least lateral end 529 extending adjacent lateral flank
19. In a similar manner, with compressive force still applied by
the healthcare provider to support device 300, elongate fixation
member 530 is extended laterally of the anal orifice 38 out of the
gluteal cleft 13 and is secured to anchor pad 534 with at least
lateral end 539 extending adjacent lateral flank 18. Thus, the
fixation members 520 and 530 of the system 500 do not extend along
the gluteal cleft 13 with the potential for interference with the
birthing process but instead extend substantially laterally from
the patient's midline out of the gluteal cleft 13.
[0053] The extent of tissue deformation surrounding the anal
orifice 38 is a function of the patient anatomy and of the amount
of compressive force applied during application of the support
device 300. In one aspect, the health care provider makes initial
contact with anal orifice 38 and then applies pressure in the
saggital plane (generally toward the patient's head) to advance the
device 1 cm to 3 cm. This advancement of the device approximately 1
cm to 3 cm compresses the perianal tissue and thereby supports the
tissue to inhibit distention as the patient pushes during the
birthing process. It will be appreciated that with the illustrated
embodiment, the healthcare provider may reposition the device and
adjust the compressive force applied through the compression
members 330 and 340 to the pressure surface 312 by releasing or
adjusting the attachment between the anchor pads 524/534 and the
fixation members 520 and 530
[0054] In an alternative approach, the pad 410 and pressure surface
312 are positioned in engagement with the anal orifice with little
if any compressive force applied to deform the perianal tissue. The
support device is then secured in position as described above. With
this technique, the support device will resist movement of the
device in a direction generally away from the patient's head and
will thereby support the perianal tissue to maintain its
position.
[0055] As shown in FIG. 19, the distance D2 between the anal
orifice and the buttocks crown 16 is less than the distance D3
between the distal end 546 of compression member and the anal
orifice. The distance D3 represents the length or extent of the
compression member 340 as measured in the saggital plane. In one
aspect, this length is greater than 3 cm. In another aspect, as
shown, the distance D3 is approximately 6 cm. Thus, tension applied
to fixation member 530 is transferred through compression member
340 to exert a compressive force on pressure surface 312. As
previously described above with respect to FIG. 4, tension force
applied to the flexible fixation members in the direction of arrows
A2 and A3 are converted to compressive forces A4 and A5,
respectively resulting in compression at the pressure surface 312
in the direction of arrow A1 directed inwardly toward the anal
orifice.
[0056] Referring now to FIG. 20, with system 500 in position, a
healthcare provider is allowed to position one or both hands 600
within the access cavity 350 extending into the gluteal cleft. In
this manner, the hands 600 may be below the lowest portion 9 of the
vaginal opening 11 as the head of the baby 12 passes out of the
vagina. Thus, the hand within the access cavity 350 is positionable
less than 1 cm from the mother's vaginal opening or perineum so the
healthcare provider may support the head of the baby as is it is
being born. The position of second end 316 of the support device
300 also allows access to the tissue immediately below the vaginal
opening 11 in the event an obstetric maneuver, such as an
episiotomy, manipulation of the fetus, etc., is necessary. Further,
as discussed above, in one aspect the support device 300 is quickly
repositioned or removed by releasing at least one of the straps
from the anchor pads, an obstetric maneuver is performed, the
device 300 is repositioned in a supporting position adjacent the
anus and the anchoring straps are repositioned on the anchor
pads.
[0057] In one embodiment, the support system is formed of
biocompatible material suitable for contact with human tissue.
Moreover, in one embodiment, the device is provided sterile in a
package for single use application on a patient, although reusable
devices according to the present teachings are also disclosed in
the present description. In the single use type of embodiment, the
device is cost effectively manufactured such that it is discarded
after use. For example, the device 300 is formed by of a
substantially rigid polycarbonate material. In one aspect, the
device 300 is injection molded to substantially its final V-shaped
form. The compliant pad 412 is then applied to the apex and
fixation members 520 and 530 are joined to the compression members
via an adhesive. It is contemplated that fixation members 520 and
530 may be riveted, snapped or otherwise fixedly attached to the
compression members. Still further, in a different embodiment,
fixation member 520 is passed through a channel or other opening
associated with the compression members to loosely and/or removably
join the fixation member to the compression device. In one aspect,
compression member 520 is a loop portion of a hook and loop
fastening system, such as sold under the tradename VELCRO.
[0058] It is contemplated that in other embodiments, the device 300
is formed by compression molding, transfer molding, reactive
injection molding, extrusion, blow molding, casting, heat-forming,
machining, deforming a sheet, bonding, joining or combinations
thereof. In other embodiments, suitable materials for device 300
include polymers, metals, ceramics or combinations thereof. The
materials can be or include alone or in combination: hard solids,
soft solids, tacky solids, viscous fluid, porous material, woven
fabric, braided constructions, or non-woven mesh. Examples of
polymers include polyethylene, polyester, Nylon, Teflon,
polyproplylene, polycarbonate, acrylic, PVC, styrene, PEEK, etc.
Examples of ceramics include alumina, zirconia, carbon, carbon
fibers, graphites, etc. Examples of suitable metals include
titanium, stainless steel, cobalt-chrome, etc.
[0059] It is contemplated that in still further embodiments, the
complaint pad 412 can be made from or includes at least one of the
following, either alone or in combination: woven fabric, non-woven
mesh, foam, film, porous sheet, and non-porous sheet. At least the
device 300 and compliant pad 412 are sterilized by know techniques;
such as ethylene oxide gas, gas plasma, electron-beam radiation or
gamma radiation. Such materials are available from various
suppliers such as 3M. In a similar manner, the fixation members or
straps may be formed of hook and loop fastening systems available
from 3M. Adhesive fixation systems may be adhesive a Rayon woven
tape on a liner (1538L from 3M). The tape may include liners to
prevent premature tape adhesion. In one embodiment, the liners
include a cut between the midline end adjacent device 300 and the
lateral end. During initial placement, the device is pushed against
the anus with a first hand. The opposite hand spreads the butt
check away from the device while the first hand pushes the base to
get further compressive penetration in the gluteal cleft. The hands
are switch and the steps are repeated on the opposite butt check.
After position the device, the liners adjacent the device 300 are
sequentially removed and adhered to the medial portion of the
buttocks for provisional positioning of the device. Once the device
is provisionally positioned, the first lateral liner is removed and
with pressure applied to the device, the lateral tape segment is
adhered to the patient in a final supporting position to supply
compressive force to the device. This step is repeated on the
opposite side for final fixation.
[0060] The present invention also contemplates a kit that includes
one or more of the components described above provided in a
package. In one embodiment, the kit includes at least a sterilized
perianal support device. In another aspect, the kit further
includes an anchoring assembly as described above. In this
embodiment, the anchoring assembly may be preassembled with the
perianal support device as shown in the drawings or may be provided
unassembled. In the unassembled kit, a health care provider will
remove the support device and anchoring assembly from the packaging
and assembly the support device with the anchoring assembly. As set
forth above, the anchoring assembly may be adhered to the support
assembly near the patient or the support assembly may include
fastening members or apertures to receive elements of the anchoring
assembly. For example, the support device may include an aperture
and a portion of a flexible strap may be threaded through the
aperture to join the two components. In still a further embodiment,
the kit includes a treating compound to apply to the patient. In
one such embodiment, the treating compound is provided in a
separate package. In an alternative embodiment, the treating
compound is applied to or incorporated into the support device on
the perianal contact surface.
[0061] The foregoing outlines features of several embodiments so
that those skilled in the art may better understand the aspects of
the present disclosure. Those skilled in the art should appreciate
that they may readily use the present disclosure as a basis for
designing or modifying other processes and structures for carrying
out the same purposes and/or achieving the same advantages of the
embodiments introduced herein. Those skilled in the art should also
realize that such equivalent constructions do not depart from the
spirit and scope of the present disclosure, and that they may make
various changes, substitutions and alterations herein without
departing from the spirit and scope of the present disclosure.
Furthermore, although elements of the described embodiments may be
described or claimed in the singular, the plural is contemplated
unless limitation to the singular is explicitly stated.
Additionally, all or a portion of any aspect and/or embodiment may
be utilized with all or a portion of any other aspect and/or
embodiment.
* * * * *